A review of legal, regulatory, and policy aspects of blood transfusion services in India: Issues, challenges, and opportunities

Background: Blood transfusion services (BTS) in India have progressed significantly during the last three decades. However, there is still inequity in the availability and access to blood due to various demand and supply-side issues. Appropriate laws, regulations, policies, and guidelines are critic...

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Autores principales: Joy John Mammen, Edwin Sam Asirvatham, Charishma Jones Sarman, Varsha Ranjan, Bimal Charles
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Publicado: Wolters Kluwer Medknow Publications 2021
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Acceso en línea:https://doaj.org/article/686e5e68f10c4569b867164472f3154a
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spelling oai:doaj.org-article:686e5e68f10c4569b867164472f3154a2021-11-12T10:08:28ZA review of legal, regulatory, and policy aspects of blood transfusion services in India: Issues, challenges, and opportunities0973-62471998-356510.4103/ajts.AJTS_65_20https://doaj.org/article/686e5e68f10c4569b867164472f3154a2021-01-01T00:00:00Zhttp://www.ajts.org/article.asp?issn=0973-6247;year=2021;volume=15;issue=2;spage=204;epage=211;aulast=Mammenhttps://doaj.org/toc/0973-6247https://doaj.org/toc/1998-3565Background: Blood transfusion services (BTS) in India have progressed significantly during the last three decades. However, there is still inequity in the availability and access to blood due to various demand and supply-side issues. Appropriate laws, regulations, policies, and guidelines are critical to ensure universal access to blood.Aims and Objectives: This article aims to review the evolution and current status of legal, regulatory, and policy framework and analyses the issues, challenges, and opportunities for improvement of BTS in India.Methods: This article is based on an extensive review of currently available literature and government documents.Results: The review highlights the gaps and challenges in terms of licensing, safety and quality, voluntary blood donations, the organization of BTS, access to services, and regulatory bodies. The findings emphasize the need for a coordinated response by either the National Blood Transfusion Council or a newly established autonomous “National Blood Authority” consisting of technical, administrative, and legal experts which must be exclusively responsible for regulating the BTS. As adherence to quality management systems in blood banks is not a mandatory requirement, it recommends a legal measure to ensure mandatory quality assurance in blood banks and storage centers. Towards ensuring efficiency and universal access to blood, this article recommends evidence-based criteria for establishing new blood banks to avoid skewed distribution of blood banks, component separation facilities, and blood storage centers.Conclusion: The review emphasizes the need for periodic reviews and updates of the legal, regulatory and policy framework, considering the rapid developments and technical advancements with increasingly complex systems and processes in transfusion medicine.Joy John MammenEdwin Sam AsirvathamCharishma Jones SarmanVarsha RanjanBimal CharlesWolters Kluwer Medknow Publicationsarticleavailability and access to blood transfusionblood safety and qualityblood transfusion services in indialegalregulatory and policy aspectsDiseases of the blood and blood-forming organsRC633-647.5ENAsian Journal of Transfusion Science, Vol 15, Iss 2, Pp 204-211 (2021)
institution DOAJ
collection DOAJ
language EN
topic availability and access to blood transfusion
blood safety and quality
blood transfusion services in india
legal
regulatory and policy aspects
Diseases of the blood and blood-forming organs
RC633-647.5
spellingShingle availability and access to blood transfusion
blood safety and quality
blood transfusion services in india
legal
regulatory and policy aspects
Diseases of the blood and blood-forming organs
RC633-647.5
Joy John Mammen
Edwin Sam Asirvatham
Charishma Jones Sarman
Varsha Ranjan
Bimal Charles
A review of legal, regulatory, and policy aspects of blood transfusion services in India: Issues, challenges, and opportunities
description Background: Blood transfusion services (BTS) in India have progressed significantly during the last three decades. However, there is still inequity in the availability and access to blood due to various demand and supply-side issues. Appropriate laws, regulations, policies, and guidelines are critical to ensure universal access to blood.Aims and Objectives: This article aims to review the evolution and current status of legal, regulatory, and policy framework and analyses the issues, challenges, and opportunities for improvement of BTS in India.Methods: This article is based on an extensive review of currently available literature and government documents.Results: The review highlights the gaps and challenges in terms of licensing, safety and quality, voluntary blood donations, the organization of BTS, access to services, and regulatory bodies. The findings emphasize the need for a coordinated response by either the National Blood Transfusion Council or a newly established autonomous “National Blood Authority” consisting of technical, administrative, and legal experts which must be exclusively responsible for regulating the BTS. As adherence to quality management systems in blood banks is not a mandatory requirement, it recommends a legal measure to ensure mandatory quality assurance in blood banks and storage centers. Towards ensuring efficiency and universal access to blood, this article recommends evidence-based criteria for establishing new blood banks to avoid skewed distribution of blood banks, component separation facilities, and blood storage centers.Conclusion: The review emphasizes the need for periodic reviews and updates of the legal, regulatory and policy framework, considering the rapid developments and technical advancements with increasingly complex systems and processes in transfusion medicine.
format article
author Joy John Mammen
Edwin Sam Asirvatham
Charishma Jones Sarman
Varsha Ranjan
Bimal Charles
author_facet Joy John Mammen
Edwin Sam Asirvatham
Charishma Jones Sarman
Varsha Ranjan
Bimal Charles
author_sort Joy John Mammen
title A review of legal, regulatory, and policy aspects of blood transfusion services in India: Issues, challenges, and opportunities
title_short A review of legal, regulatory, and policy aspects of blood transfusion services in India: Issues, challenges, and opportunities
title_full A review of legal, regulatory, and policy aspects of blood transfusion services in India: Issues, challenges, and opportunities
title_fullStr A review of legal, regulatory, and policy aspects of blood transfusion services in India: Issues, challenges, and opportunities
title_full_unstemmed A review of legal, regulatory, and policy aspects of blood transfusion services in India: Issues, challenges, and opportunities
title_sort review of legal, regulatory, and policy aspects of blood transfusion services in india: issues, challenges, and opportunities
publisher Wolters Kluwer Medknow Publications
publishDate 2021
url https://doaj.org/article/686e5e68f10c4569b867164472f3154a
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